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14/09 Neha Taneja
HR Professional at Stryker

Views:1436 Applications:329 Rec. Actions:Recruiter Actions:26

Stryker - Quality Engineer/Senior Quality Engineer - Mechanical Engineering (3-7 yrs)

Gurgaon/Gurugram Job Code: 15327

Quality Engineer or Senior Quality Engineer AQE

AQE to drive overall quality approach during new product / process development. Drive coordination with different departments (such a R&D, AME, ME, Regulatory, Post Market Quality) to ensure the resulting part/product/process are safe, compliant and effective. Good understanding of customer need and shall guide the team to achieve process/product compliance, safety, reliability & effectiveness.

- Minimum Qualifications :

Education : B. Tech / B.E / M. Tech / M.S. - Mechanical Engineering

Experience: Experience: 3-6 years

Technical Skill Set :

- Experience on Medical Device Development process

- Experience on New Product Development process and various phases of new product development.

- Experience on Risk Management, different Risk Analysis tools and techniques

- Experience on ISO 14971, IEC 62304, 60601-1 family of standards

- Understanding of Quality Management Systems. (ISO 13485, 21 CRF 820, ISO 9001)

- Understanding of design requirement specification, detailed design requirements, Engineering Drawings, Verification & Testing documents, Product Validation documents

- Awareness on techniques used for Product Evaluation

- Experience on reviewing Design Outputs, Device Master Record, and Design History File

- Experience with various Quality Management & Quality Control tools

- Understanding of the concepts of PPAP & Advance Product Quality Planning

- Experience on Basic Statistics

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

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